regulatory
confidence high
sentiment positive
materiality 0.70
FDA approves TherapeuticsMD's ANNOVERA sNDA, boosting supply by ~7,000 rings
TherapeuticsMD, Inc.
- FDA approved sNDA for ANNOVERA with revised in vitro release testing specification to allow normal manufacturing variability.
- Company expects ~7,000 additional rings to enter supply chain in Q2/Q3 2022, reducing batch rejections.
- CEO Hugh O'Dowd says approval enables scaling production to meet increasing customer demand for procedure-free birth control.